Stock Market & Financial Investment News

Mylan settles patent litigation related to Celebrex capsules with PfizerMylan (MYL) announced that it has entered into a settlement and license agreement with Pfizer (PFE) relating to Mylan's Abbreviated New Drug Application filed with the FDA for Celecoxib Capsules, 50 mg, 100 mg, 200 mg and 400 mg. This product is the generic version of Celebrex, which is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Under the terms of the agreement, Mylan will begin selling product at the earliest market formation, however in any case not later than December. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. Additionally, Mylan has appealed the decision by the United States District Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against the FDA. Mylan continues to believe that FDA seriously erred in its decision awarding one party eligibility for 180 days of exclusivity on Celecoxib, and will continue with this suit independent of the aforementioned settlement.

Mylan completes acquisition of assets from AbbottMylan N.V. and Mylan (MYL) announced the successful completion of the acquisition of Abbott Laboratories' (ABT) non-U.S. developed markets specialty and branded generics business. Under the previously announced terms of the transaction agreement, Abbott received 110M shares of Mylan N.V., resulting in former Mylan shareholders now owning approximately 78% of Mylan N.V. and Abbott now owning approximately 22% of Mylan N.V. Mylan Inc. and Abbott's non-U.S. developed markets specialty and branded generics business have been reorganized under Mylan N.V., a new public company organized in the Netherlands. Mylan N.V. will be led by the former Mylan Inc. executive team. The company will trade on Nasdaq under the ticker symbol MYL.

Pfizer announces FDA acceptance of NDA for RapamunePfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.

Tianyin JCM plans for FDA certification process Tianyin Pharmaceutical (TPI) updated on the business and development at its Jiangchuan Macrolide Facility, or JCM, active pharmaceutical ingredients operation. In addition to JCM's certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer's (PFE) and their subsidiaries in China, the company said. "This is expected to translate to further demand for JCM's macrolide API business in both the domestic and international markets," Tianyin stated.